Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients
25. maj 2017 opdateret af: GlaxoSmithKline
The purpose of this study is to assess the predictive ability of three asthma risk markers: the ratio of controller medication to total asthma medication, an albuterol only marker, and an oral corticosteroid use marker, as well as to compare the precision of these tools between adult and pediatric patient populations.
This retrospective longitudinal analysis will use 2 different databases: a large managed care database and a large fee for service Medicaid database.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
101437
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
4 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
The study intends to identify subjects at least 4 years of age with asthma and using asthma medications
Beskrivelse
Inclusion Criteria:
- Subjects with asthma as determined by ICD-9 codes and asthma drug use
- at least 4 years of age
- use of at least 1 controller or at least 5 albuterol prescriptions in 12 months
Exclusion Criteria:
- Subjects with COPD or treatment for COPD
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Pediatric participants
Pediatric participants (age 4 to 17) with a diagnosis of asthma
|
participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol.
|
|
Adult participants
Adult participants (age 18 and older) with a diagnosis of asthma
|
participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Ratio of Controller Medication to Total Asthma Medication
Tidsramme: January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods
|
The ratio of controller medication (CM) to total asthma medication (AM), which is well established in predicting future asthma events in adults, was calculated as the ratio of the units of CMs used during the defined period divided by the sum of the units of CMs plus the units of inhaled short-acting beta-agonists used during the same period.
A CM is defined as any inhaled corticosteroid containing medication, methylxanthines, leukotriene receptor antagonists, or cromolyn sodium.
The ratio is calculated using all CM.
Asthma controllers are medications used to treat asthma on a regular basis.
|
January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Number of Short-acting Beta-agonist (SABA) Canisters Used
Tidsramme: January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods
|
The number of albuterol canisters dispensed is a marker that is well established in predicting future asthma events in an adult population.
|
January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2009
Primær færdiggørelse (Faktiske)
1. april 2010
Studieafslutning (Faktiske)
1. april 2010
Datoer for studieregistrering
Først indsendt
15. april 2011
Først indsendt, der opfyldte QC-kriterier
2. maj 2011
Først opslået (Skøn)
3. maj 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. maj 2017
Sidst verificeret
1. maj 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 112607
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